Various implementations of medical specula for use by a medical professional in enlarging an anatomical aperture in a patient's body for purposes of medical examination are widely known. Examples include, but are not limited to, nasal specula, ear specula, anal specula, and vaginal specula.
Specula are important medical instruments that serve as accurate and expedient means for providing examination and treatment of the anatomical apertures that are the subject of such examination and treatment. Specifically, a vaginal speculum is integral to the examination and treatment of the vagina and related areas. Medical practitioners require a vaginal speculum that lends itself to manual dexterity. The design of the conventional vaginal speculum enables the blades to be sufficiently movable to provide not only parallel but angularly displaced adjustment of the blades over a wide range of separation.
A known speculum is disclosed in U.S. Pat. No. 4,807,600 to Hayes. Speculum includes a handle and an adjustable arm coupled to the handle about a hinge. A first blade is integrally formed with handle, and a second blade is integrally formed with the adjustment arm. A first blade is a lower blade of the speculum, and second blade is an upper blade. Each blade includes an inner surface and an outer surface, where the outer surfaces are those surfaces oriented to contact tissue of the patient. Movement of a thumb piece results in moving upper blade relative to lower blade about a hinge. A locking device is provided to secure thumb piece in position to maintain a desired position of blades during a gynecological exam.
There are other known speculum configurations, but generally each configuration includes a rigid lower blade and a rigid upper blade, both blades composed of metal such as stainless steel or rigid plastic material. During use, the blades are closed together and inserted in combination into the vaginal cavity. Thumb piece is depressed to separate upper blade from lower blade, thus expanding the walls of the vaginal cavity. Locking device is engaged to secure blades in their desired position. The medical practitioner is then able to examine and treat the vagina, vaginal sidewalls, and uterine cervix.
Speculum configurations composed of stainless steel are preferred by many medical practitioners due to both cost and waste concerns involved in use of disposable plastic alternatives. However, due to mass production of solid components that can result in sharp, uneven edges, use of conventional speculum composed of stainless steel can result in patient discomfort. Both plastic composed and stainless steel composed speculum in most conventional configurations include a lower blade and an upper blade with opposing concavo-convex blade surfaces that provide a concave walled viewing and access channel therebetween when separated or opened, commonly referred to as a duckbill speculum. In use, duckbill speculum can impair visibility for the medical practitioner conducting the examination and treatment, which can result in longer examination times, reduced thoroughness, decreased accuracy and increased patient discomfort.
Various types of specula blade sheaths and specula blade covers are well known. Examples of some designs for specula blade sheaths are disclosed in U.S. Pat. No. 5,460,165 and U.S. Pat. No. 5,007,409. Examples of some designs for specula blade covers are disclosed in U.S. Pat. No. 4,492,220, U.S. Pat. No. 3,851,642, and U.S. Pat. No. 4,807,600. However, speculum blade covers and sheaths known in the prior art fail to provide lateral and distal extension capabilities. The prior art discloses devices that are both disposable and reusable. In addition, the prior art discloses devices that address medical practitioner concerns or patient concerns, individually. The present invention differs from these examples. The present invention is composed of soft, flexible, reusable silicone and provides extension capabilities not disclosed in the prior art. Further, the prior art does not adequately address both medical practitioner and patient concerns, collectively.
The present invention improves on the prior art by providing a device that resolves both medical practitioner and patient concerns. The present invention increases visibility of the vagina, vaginal sidewalls, and uterine cervix whereas the prior art does not disclose blade covers or sheaths that provide extension or expansion capabilities. Medical practitioners that perform pelvic examinations infrequently can use the present invention with its extension capabilities to perform more accurate, efficient, and comfortable examinations. The present invention is composed of semi-rigid silicone material which causes less tissue trauma. By example, women ranging from atrophic postmenopausal women to nulliparous women to virginal women can be easily emotionally and physically traumatized by metal and plastic speculums resulting in bleeding and pain that can affect the accuracy, thoroughness and duration of examinations. The present invention provides for interchangeable blade extenders of different sizes to customize a speculum to a patient's anatomical design. Further, the present invention is comprised of extenders that are standardized to fit a small size speculum and will, therefore, reduce medical practitioners' requirements to purchase multiple sized specula. The present invention is reusable and sterilizable resulting in reduced waste.
Further, the present invention also addresses patient concerns such as comfort. Some women may be averse to scheduling routine or medically necessary pelvic examinations due to fear of discomfort or pain. Further, a patient may have access to only one, novice medical practitioner in a rural or disadvantaged area and may avoid an examination. The present invention provides a more comfortable, more efficient, user-friendly design that can relieve these fears and uncertainties.
Therefore, it is an object of the present invention to provide a device that addresses the concerns of both medical practitioner and patient.